Z-0646-2017Class II

Pathfast D-Dimer, Reference number: PF1051-KUS

Name: Z-0646-2017 Pathfast D-Dimer, Reference number: PF1051-KUS
Creator: Lsi Medience Corporation
Published: 2016-08-16
License: https://open.fda.gov/license/

Lsi Medience Corporation / initiated 2016-08-16 / Terminated / root cause: manufacturing process

FDA source

Lsi Medience Corporation began a recall of Pathfast D-Dimer, Reference number: PF1051-KUS on 2016-08-16. FDA classified it as Class II and gives the reason as "Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0646-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-16
Posted: 2016-11-21
Terminated: 2017-02-27
Recalling firm: Lsi Medience Corporation
Product: Pathfast D-Dimer, Reference number: PF1051-KUS
Product code: GHH Fibrin Split Products
Reason for recall: Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Customers were notified by letter sent via email on/about August 1, 2016. They were instructed to stop using and destroy the affected kits. They were to perform a retrospective analysis of the patients tested on the batch and investigate further. A Destruction Certificate was attached to be completed and returned to Verbatim Americas, LLC. For further questions please call (704) 547-6517.
Quantity in commerce: 42 boxes (each containing 60 test cartridges/one kit contains 10 reagent cartridge trays and one tray has 6 cartridges).
Distribution: US Distribution to the states of : AL, FL, ID and MA.
Product codes and lots: Lot T528

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0646-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0646-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-21

Product code GHH

K072288Class IIPathfast D-DimerMitsubishi Kagaku Iatron / cleared 2009-05-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)